Back to resultsEvaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
Primary Purpose
Hair Loss, Nails, Ingrown
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
A power supplement with biotin
Sponsored by
About this trial
This is an interventional treatment trial for Hair Loss focused on measuring capillary density, strengthening, hair loss
Eligibility Criteria
Inclusion Criteria: Phototype (Fitzpatrick): I to VI. Have intact skin in the test region: scalp. Present a clinical diagnosis of telogen effluvium. Agree to adhere to the study procedures and requirements: study time, returns (D-3, D0, D45, D48,D90 and D93) to the laboratory to carry out the study procedures, administration of the product research, fill the use diary, fill the perceived efficacy questionnaire, carrying out the collection of hair samples (hair cut, close to the scalp - beginning of the study and after 90 days), not change hair habits during the study period. Agree not to carry out chemical hair treatments (hair coloring, straightening, among others) and/or treatment to control/reduce hair loss and/or dandruff, among others, until the end of the study (90 days). Agree with the procedure for collecting hair samples: trichogram and hair cut, close to the leather hairy. Agree to administer 01 capsule/day of the investigational product. Present a minimum length of hair (3 cm) to carry out the procedure for collecting samples of hair Present hair and brittleness for at least 3 months before the start of the study. Signature of the Free and Informed Consent Term (TCLE). Exclusion Criteria: Pregnancy During the course of the study, the subject develops symptoms of COVID-19, such as: fever (temperature above 37.5°C), cough; dyspnoea (difficulty breathing characterized by rapid, short breaths, usually associated with heart or lung disease); myalgia (muscle pain); upper respiratory symptoms; fatigue and more rarely, gastrointestinal symptoms. Appearance of disease that requires the use of medications prohibited in this protocol: use of corticoids and anti-inflammatories for a period longer than 15 days and/or in high doses (above 1mg/kg). Use of immunosuppressants during the study period. Use of Vitamin A or its derivatives and other vitamins and minerals. Beginning or changing hormone treatments after signing the TCLE. Swallowing difficulty: dysphagia. Presence of dermatoses or active skin lesions (local and/or disseminated) in the study region. Hypersensitivity reactions (allergic reactions, irritation or feelings of discomfort) caused by actives or excipients from the investigational product. Vaccine use during the study period. Diagnosis of diabetes or nephropathies during the study period.
Sites / Locations
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A power supplement with biotin
Arm Description
40 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage
Outcomes
Primary Outcome Measures
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
Evaluate the effectiveness of the product investigational in providing reduction of hair loss through thrichogram analysis. If the ratio between anagen/telogen hairs strands is > 4, it indicates improvement in reducing hair loss after daily and continuous use for a period of up to 90 days.
Secondary Outcome Measures
Analysis of the biological cycle of hair growth- Trichogram
Evaluate the phase of the biological cycle of hair growth (anagen, telogen or catagen) and determine the ratio between anagen/telogen hair strands. If the ratio between anagen/telogen hairs strands is ≤ 4, it indicates positive symptoms for androgenetic alopecia or telogen effluvium and the partipant will be included in the study.The trichogram was performed three days before the beginning of product intake, and after 45 days and 90 days of continuous use.
Evaluation of hair growth kinetics- Phototrichogram
Evaluate the growth kinetics of hair strands after shaving a standardized area of 1 cm² of the scalp and taking images on the same day and three days after. In total, three scrapings were performed on three days before intervention, day 45 and day 90, totaling six image collections. A microscope (i-Scope USB, Moritex, JP) with a 30x lens and polarized light was used to obtain the images. In each collection, three microimages of the evaluated area on the head of each participant were recorded.
Monitoring of hair growth by photographic documentation
Evaluation of the dermal thickness of hair strands through specific software. Patients will be submitted to the Ultrascan UC 22 MHz equipment (Courage + Khazaka electronic GmbH), on day 0 and after 45 days and 90 days of continuous use of the investigational product.
Evaluation of the mechanical strength of the hair structure using EMIC DL 500
Evaluation of the mechanical resistance of the hair. 50 hairs strands were collected from each participant and cut with the aid of scissors to avoid possible damage to the hair shaft resulting from traction for pulling out. The test was performed three days before the beginning of product intake and after 90 days of continuous use.
Subjective efficacy of the participants by questionnaire
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 days e 90 days of continuous use of the product. The questionnaire uses a 7-point scale, where 1 meaning poor and 7 means excellent.
Full Information
NCT ID
NCT05945979
First Posted
May 26, 2023
Last Updated
July 13, 2023
Sponsor
Farmoquimica S.A.
Collaborators
Kosmoscience Ciência e Tecnologia Cosmética Ltda
1. Study Identification
Unique Protocol Identification Number
NCT05945979
Brief Title
Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
Official Title
Avaliação da eficácia de um Novo Suplemento Alimentar Para Cabelos e Unhas- Estudo in Vitro, clínico, Subjetivo e Instrumental
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Farmoquimica S.A.
Collaborators
Kosmoscience Ciência e Tecnologia Cosmética Ltda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical,in vitro, subjective and instrumental evaluations
Detailed Description
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical, in vitro, subjective and instrumental evaluations.
It will be necessary 40 female participants aged between 25 and 55 years old with a clinical and in vitro diagnosis of telogen effluvium presenting at least one of the following characteristics: hair loss problems caused by stress, poor diet and excess of tinctures and chemicals procedures applied to hair, and menopausal women.
The participants will remain in the study for 93 days using the product. Visits will be scheduled in D-3, D0, D45, D48, D90, D93.
Instrumental evaluations: Evaluated on each visit:
To analyze the biological cycle of hair growth using Trichogram test - D-3, D45, D90;
Evaluation of hair growth kinetics using phototrichogram - D-3,D0, D45, D48, D90, D93;
Evaluation of the mechanical strength of the hair structure using EMIC DL 500- D-3, D90
Evaluation of the dermal density of the scalp using the high-frequency ultrasound- D-3, D45, D90
Participants will respond to a subjective assessment using a questionnaire to capture a subjective efficacy- D45, D90
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss, Nails, Ingrown
Keywords
capillary density, strengthening, hair loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A power supplement with biotin
Arm Type
Experimental
Arm Description
40 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage
Intervention Type
Dietary Supplement
Intervention Name(s)
A power supplement with biotin
Intervention Description
A power dietary supplement containing aminoacids and vitamins
Primary Outcome Measure Information:
Title
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
Description
Evaluate the effectiveness of the product investigational in providing reduction of hair loss through thrichogram analysis. If the ratio between anagen/telogen hairs strands is > 4, it indicates improvement in reducing hair loss after daily and continuous use for a period of up to 90 days.
Time Frame
Day 93
Secondary Outcome Measure Information:
Title
Analysis of the biological cycle of hair growth- Trichogram
Description
Evaluate the phase of the biological cycle of hair growth (anagen, telogen or catagen) and determine the ratio between anagen/telogen hair strands. If the ratio between anagen/telogen hairs strands is ≤ 4, it indicates positive symptoms for androgenetic alopecia or telogen effluvium and the partipant will be included in the study.The trichogram was performed three days before the beginning of product intake, and after 45 days and 90 days of continuous use.
Time Frame
Three days before the beginning of product intake, Day 45 and Day 90
Title
Evaluation of hair growth kinetics- Phototrichogram
Description
Evaluate the growth kinetics of hair strands after shaving a standardized area of 1 cm² of the scalp and taking images on the same day and three days after. In total, three scrapings were performed on three days before intervention, day 45 and day 90, totaling six image collections. A microscope (i-Scope USB, Moritex, JP) with a 30x lens and polarized light was used to obtain the images. In each collection, three microimages of the evaluated area on the head of each participant were recorded.
Time Frame
Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93
Title
Monitoring of hair growth by photographic documentation
Description
Evaluation of the dermal thickness of hair strands through specific software. Patients will be submitted to the Ultrascan UC 22 MHz equipment (Courage + Khazaka electronic GmbH), on day 0 and after 45 days and 90 days of continuous use of the investigational product.
Time Frame
Day 0, Day 45 and Day 90
Title
Evaluation of the mechanical strength of the hair structure using EMIC DL 500
Description
Evaluation of the mechanical resistance of the hair. 50 hairs strands were collected from each participant and cut with the aid of scissors to avoid possible damage to the hair shaft resulting from traction for pulling out. The test was performed three days before the beginning of product intake and after 90 days of continuous use.
Time Frame
Three days before the beginning of product intake and Day 90
Title
Subjective efficacy of the participants by questionnaire
Description
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 days e 90 days of continuous use of the product. The questionnaire uses a 7-point scale, where 1 meaning poor and 7 means excellent.
Time Frame
Day 45 and Day 90
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Phototype (Fitzpatrick): I to VI.
Have intact skin in the test region: scalp.
Present a clinical diagnosis of telogen effluvium.
Agree to adhere to the study procedures and requirements: study time, returns (D-3, D0, D45, D48,D90 and D93) to the laboratory to carry out the study procedures, administration of the product research, fill the use diary, fill the perceived efficacy questionnaire, carrying out the collection of hair samples (hair cut, close to the scalp - beginning of the study and after 90 days), not change hair habits during the study period.
Agree not to carry out chemical hair treatments (hair coloring, straightening, among others) and/or treatment to control/reduce hair loss and/or dandruff, among others, until the end of the study (90 days).
Agree with the procedure for collecting hair samples: trichogram and hair cut, close to the leather hairy.
Agree to administer 01 capsule/day of the investigational product. Present a minimum length of hair (3 cm) to carry out the procedure for collecting samples of hair
Present hair and brittleness for at least 3 months before the start of the study.
Signature of the Free and Informed Consent Term (TCLE).
Exclusion Criteria:
Pregnancy
During the course of the study, the subject develops symptoms of COVID-19, such as: fever (temperature above 37.5°C), cough; dyspnoea (difficulty breathing characterized by rapid, short breaths, usually associated with heart or lung disease); myalgia (muscle pain); upper respiratory symptoms; fatigue and more rarely, gastrointestinal symptoms.
Appearance of disease that requires the use of medications prohibited in this protocol: use of corticoids and anti-inflammatories for a period longer than 15 days and/or in high doses (above 1mg/kg).
Use of immunosuppressants during the study period.
Use of Vitamin A or its derivatives and other vitamins and minerals.
Beginning or changing hormone treatments after signing the TCLE.
Swallowing difficulty: dysphagia.
Presence of dermatoses or active skin lesions (local and/or disseminated) in the study region.
Hypersensitivity reactions (allergic reactions, irritation or feelings of discomfort) caused by actives or excipients from the investigational product.
Vaccine use during the study period.
Diagnosis of diabetes or nephropathies during the study period.
Facility Information:
Facility Name
Kosmoscience Ciência e Tecnologia Cosmética Ltda
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13270-180
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
D93
Learn more about this trial
Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
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